Aloxi

RSS

palonosetron

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Aloxi. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aloxi.

This EPAR was last updated on 19/07/2018

Authorisation details

Product details
Name
Aloxi
Agency product number
EMEA/H/C/000563
Active substance
palonosetron hydrochloride
International non-proprietary name (INN) or common name
palonosetron
Therapeutic area (MeSH)
  • Vomiting
  • Cancer
Anatomical therapeutic chemical (ATC) code
A04AA05
Publication details
Marketing-authorisation holder
Helsinn Birex Pharmaceuticals Ltd.
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
22/03/2005
Contact address

Damastown
Mulhuddart
Dublin 15
Ireland

Product information

26/04/2018 Aloxi - EMEA/H/C/000563 - II/0045/G

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Anti emetics and antinauseants

Therapeutic indication

Aloxi is indicated in adults for:

  • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,
  • the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Aloxi is indicated in paediatric patients 1 month of age and older for:

  • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Assessment history

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